NCT07294001

Shame-Focused Cognitive Behavioral Therapy For Reducing Suicide Risk In Adolescent Psychiatric Inpatients (SF-CBT)

A Pilot Randomized Controlled Trial Of Shame-Focused Cognitive Behavioral Therapy For Suicide Prevention In Adolescent Psychiatric Inpatients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 13 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot randomized controlled trial (RCT) aims to evaluate the feasibility, acceptability, and preliminary efficacy of Shame-Focused Cognitive Behavioral Therapy (SF-CBT) among high-risk psychiatric inpatient adolescents. Shame has been identified as a critical psychological mechanism underlying suicidal ideation and behavior, yet few interventions directly target it. SF-CBT is a structured, manualized intervention designed to reduce shame, improve coping strategies, and lower suicide risk. Approximately 42 adolescents aged 13-18 years, admitted for recent suicide attempt or severe suicidal ideation, will be randomized in a 2:1 ratio to receive either SF-CBT or supportive therapy (ST). Both conditions include 7 individual sessions for adolescents and 3 structured psychoeducation sessions for parents/guardians. Primary outcomes include feasibility metrics (recruitment, retention, adherence, fidelity, adverse events) and acceptability ratings from adolescents, parents, and therapists. Secondary outcomes include changes in suicidal ideation, suicidal behavior, shame, and coping styles, assessed at baseline, post-treatment, and 1-, 3-, and 6-month follow-ups. Findings will inform refinement of the intervention manual, establish feasibility benchmarks, and provide effect size estimates to guide a subsequent large-scale RCT.

Detailed description

Adolescent suicide is a major public health concern in China and worldwide. Shame, a powerful and often overlooked psychological driver of suicide risk, has rarely been the focus of intervention efforts. This study introduces and tests Shame-Focused Cognitive Behavioral Therapy (SF-CBT), a manualized and structured therapy designed specifically to reduce shame, enhance adaptive coping, and mitigate suicide risk in high-risk inpatient adolescents. Objectives The primary objective is to test the feasibility and acceptability of SF-CBT in an inpatient psychiatric setting. Secondary objectives are to explore its preliminary efficacy in reducing shame, suicidal ideation, and suicidal behavior, and to evaluate the maintenance of effects at 1-, 3-, and 6-month follow-ups. Design and Participants This is a single-site, single-blind pilot RCT conducted at Peking University Sixth Hospital adolescent psychiatric ward. Forty-two adolescents (ages 13-18) admitted with recent suicidal ideation or attempt and elevated baseline shame will be recruited. Exclusion criteria include acute mania, psychotic disorders, severe cognitive impairment, or expected hospitalization shorter than 14 days. Eligible participants will be randomized (2:1) to SF-CBT (\~28) or ST (\~14). Intervention SF-CBT: Seven 50-60 minute individual sessions covering motivation building, emotion recognition and chain analysis, shame-coping strategies, self-esteem enhancement, and relapse prevention. Parents/guardians will attend 3 psychoeducation sessions on empathic communication, crisis management, and family boundary-setting, supported by AI-based scenario simulations. Supportive Therapy (ST): Seven supportive counseling sessions focusing on emotional support and inpatient adjustment. Parent psychoeducation sessions identical to SF-CBT arm. Outcomes Primary outcomes: Feasibility (recruitment and retention rates, adherence, fidelity, adverse events) and acceptability (satisfaction ratings by adolescents, parents, therapists). Secondary outcomes: Suicidal ideation and behavior (C-SSRS, SIQ), shame (EISS), and shame-coping (CoSS), assessed at baseline, post-treatment, and 1-, 3-, and 6-month follow-ups. Analysis and Significance Feasibility benchmarks (e.g., ≥70% recruitment, ≥80% completion) will guide readiness for a full-scale RCT. Preliminary efficacy will be explored using multilevel models, with effect sizes reported to inform sample size estimation. This pilot study will establish the feasibility and safety of SF-CBT in high-risk adolescent inpatients and provide initial evidence for its impact on shame and suicide risk. Results will directly inform a larger RCT and contribute to evidence-based, mechanism-driven suicide prevention strategies for adolescents.

Conditions

• Adolescent Suicide
• Suicidal Ideation
• Suicidal Behavior
• Shame

Interventions

Type	Name	Description
BEHAVIORAL	Shame-Focused Cognitive Behavioral Therapy (SF-CBT)	A structured, manualized individual psychotherapy program consisting of 7 sessions (50-60 minutes each), delivered during hospitalization. The intervention includes modules on motivation building, emotional recognition, behavior chain analysis, shame coping strategies, self-esteem enhancement, and relapse prevention. In addition, caregivers participate in 3 psychoeducation sessions covering empathic communication, crisis response, and boundary management, supplemented by AI-assisted scenario simulations.
BEHAVIORAL	Supportive Therapy (ST)	A supportive counseling program consisting of 7 sessions (50-60 minutes each), focusing on relationship building, emotional support, and adaptation to hospitalization. Caregivers in this arm also receive 3 psychoeducation sessions identical to those in the experimental arm, covering communication, crisis management, and boundary setting, with AI-assisted practice.

Timeline

• Start date: 2025-08-10
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2025-12-19
• Last updated: 2025-12-19

Locations

1 site across 1 country: China